priti®multidisc ZrO2

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 13107-D985-10A1HT

by Pritidenta GmbH

Identity

Trade Name: priti®multidisc ZrO₂ High Translucent EUDAMED
priti®multidisc ZrO2 FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: Dental restorative devices EUDAMED
Model / Reference: 13107-D985-10A1HT EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 04251366900039 EUDAMEDFDA UDI
Basic UDI-DI: 42513669ZRO2HTRX EUDAMED
510(k) Number: K161025 FDA UDI
FDA Product Code: EIH FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental appliance fabrication material, ceramic

priti®multidisc ZrO2 by Pritidenta GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pritidenta GmbH

Sources (2)

FDA UDI e75b9861-f2b4-4f07-b548-40256c650f42 33 fields · synced Jul 23, 2026
EUDAMED 7f1b4886-a73d-496f-8b8e-c4439d9a9979 61 fields · synced Jul 23, 2026